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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021444
Receipt No. R000024698
Scientific Title Research for effectiveness and safety of branched stent-graft to aortic arch disease
Date of disclosure of the study information 2016/04/01
Last modified on 2017/06/14

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Basic information
Public title Research for effectiveness and safety of branched stent-graft to aortic arch disease
Acronym Research for effectiveness and safety of branched stent-graft to aortic arch disease
Scientific Title Research for effectiveness and safety of branched stent-graft to aortic arch disease
Scientific Title:Acronym Research for effectiveness and safety of branched stent-graft to aortic arch disease
Region
Japan

Condition
Condition aortic arch disease
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to evaluate the effectiveness and safety of branched stent graft to aortic arch disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes freedom from aortic rupture/enlargement at 6 month postoperatively
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Endovascular arotic repair
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) aortic aneurysm located aortic arch to descending aorta and the following one of features are admitted:.
1-a) the largest diameter exceeds 50mm in fusiform aneurysm
1-b) saccular aneurysm containing the risk of rupture
1-c) rapid expansionary more than 5mm/ year
1-d) symptomatic
1-e) risk of rupture or malperfusion
2) the patient who judges the average artificial blood vessel substitution way dies of more than one cardiovascular surgery medicine or, a possibility of the severe complication development is high, and that it's difficult to enforce safely.
3) treatment in aorta stentgraft approved at present doesn't possess more than 20 mm of normal blood vessel in the left common carotid branch part end, and is difficult.
I possess an aorta neck of diameter 18 suitable for stentgraft custody-42 mm in a line aorta on the 4).
5) I possess enough blood vessel access for delivery system [biggest outside diameter 26Fr (8.7 mm)] insertion.
6) after a subject had the explanation about the contents of this research, I'm signing agreement sentences.
7) an examinee and the doctor who does this research agree about that a subject goes to a hospital on all follow up days when it's necessary after hand skill operation.
Key exclusion criteria 1)underage (less than 20). 2)a untreated coronary artery disease 3)severe LV dysfunction(LVEF is less than 20%) 4)the patient with pregnancy. 5)the following one of haematological disorder.
(1)Leukocyte decrease (a leukocyte, several 1000 /mm3, less than)(2)Platelet decrease shou (a platelet, several, 50,000 /mm3, less than)(3)Haemorrhagic diathesis or blood clotting abnormality. 6)the morbid overweight patient who can't take a picture of an X-ray picture of an aorta appropriately. 7)chronic obstructive pulmonary disease which requires O Ther outside the hospital daily (COPD) is admitted. 8)it's following hyperesthesia to whether it's both or taboo, and it can't be treated appropriately beforehand.(1)Contrast medium(2)NICHINORU (titanium and nickel alloy), platinum iridium base alloy and polyester(3)Heparin
9)an active whole body infection and/or, patient with infectibility big aneurysm. 10) the past of the cerebrovascular accident (CVA) or a transient brain ischemia attack (TIA) is within 1 month old from a schedule operation day. 11)active enteron bleeding. 12)the patient diagnosed as life expectancy for less than 1 year based on a clear basis (existence of malignant tumor and aging) medically. 13)the patient who participates in a clinical trial of other medical equipment or medical supplies. 14)it seems to refuse blood transfusion. 15)serious recognition shou (As a result, it isn't possible to do the life which became independent outside the Long Term Care Facility to which an agreement explanation note can't be submitted or a hand skill and going to a hospital for follow-up won't be done for a rehabilitation.) 16)the patient who judged a doctor in attendance when it was medical to participate in clinical study psychologically and was difficult.
(anatomilcal contraindication)
beyond information for use
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideyuki Shimizu
Organization Keio University School of Medicine
Division name Department of Cardiovascular Surgery
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo 160-8582, JAPAN
TEL 03-3353-1211
Email hideyuki@keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akihiro Yoshitake
Organization Keio University School of Medicine
Division name Department of Cardiovascular Surgery
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo 160-8582, JAPAN
TEL 03-3353-1211
Homepage URL
Email akihiro197253@yahoo.co.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization Keio University School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 03 Month 08 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 03 Month 11 Day
Last modified on
2017 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024698

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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